Needle assembly with flexible catheter nose for diagnostic sampling of fluid

ABSTRACT

A needle assembly for sampling fluid from a patient including a needle guard, an insertion needle, and a needle housing. The distal end of the needle guard includes a nose portion and a flexible nose extension defining a fluid collection reservoir. The proximal end of the needle guard includes a push feature. The insertion needle has a sharpened distal tip, a proximal needle end and a shaft defining a lumen extending therebetween. The needle housing is operably coupled to the proximal needle end and is slideably coupled to the needle guard. The needle housing includes a flash chamber including a wall defining a cavity. The cavity is in fluid communication with the lumen of the insertion needle and is sealed at one end by a gas permeable flash plug. The push feature selectively engages the flash plug to divert captured bodily fluids to the fluid collection reservoir for sampling.

RELATED APPLICATION INFORMATION

The present application is a National Phase entry of PCT Application No.PCT/US2017/033478, which claims the benefit of U.S. ProvisionalApplication No. 62/339,287 filed May 20, 2016, which are herebyincorporated herein in their entirety by reference.

TECHNICAL FIELD

The present disclosure relates generally to needle assemblies, and moreparticularly to safety needle assemblies having diagnostic samplingfeatures that provide controlled access to blood or bodily fluidcaptured by the needle assemblies for testing and analysis.

BACKGROUND

Various types of intravenous (IV) therapy have been used to administermedical fluids and withdraw bodily fluids from patients. IV therapy hasbeen used for purposes such as maintenance of fluid and electrolytebalance, transfusion of blood, administration of nutritionalsupplements, chemotherapy, and administration of drugs and medications.Specifically, fluids have been administered intravenously by injectionthrough a hypodermic needle, or intermittently or continuously byinfusion using a needle or catheter. The most common intravenous accessmethod utilized by clinicians has been the peripheral IV catheter.

Peripheral IV catheters are made of soft, flexible plastic or silicone,generally between fourteen to twenty-four gauge in size. In conventionalvenipuncture procedures, a catheter is inserted into a vein in thepatient's hand, foot, or the inner aspect of the arm or any vein in thebody that will accept an IV catheter. In order to properly place the IVcatheter into a patient's vein, a sharp introducer needle is used topuncture the skin, tissue, and vein wall to provide a path for placementof the catheter.

Referring to FIGS. 1 and 2, a prior art conventional IV safety needleassembly 20, configured for insertion of an “over-the needle” catheter22, is depicted. The catheter 22 is operably coupleable to the safetyneedle assembly 20, in part by positioning the catheter 22 coaxiallyover the needle 24 of the safety needle assembly 20. The catheter 22thus rides with the needle 24 through the skin, tissue, and vein walland into the patient's vein. Often, the insertion end of the catheter 22is tapered in an effort to minimize the amount of force required toinsert the catheter 22 into the biological site.

The catheter 22 can include a catheter hub 30, which can be selectivelycoupled to a portion of the safety needle assembly 20. Catheter hub 30is sometimes configured to control the flow of fluid through thecatheter 22 via an internal fluid passageway that runs substantiallyparallel to the longitudinal axis of the catheter hub 30. In someembodiments, the fluid passageway includes a septum or valve to enablesealing of the fluid passageway to restrict or prevent bodily fluid fromleaking out of the catheter hub 30 when the catheter 22 is inserted intoa patient's vein and the needle 24 is removed.

When the needle 24 pierces the vein, blood will “flashback” through theneedle 24 and into the flash chamber 26. Thus, once the clinicianobserves this flashback of blood, the clinician will know that thecatheter 22 and needle 24 have been inserted in the vein. The catheter22 can be advanced further into the vein as desired and the needle 24can then be withdrawn from the catheter 22.

In addition to placement of an IV catheter, samples of the patient'sblood are often obtained (e.g., for testing, blood typing or otheranalysis of a patient's condition). Such analysis frequently involvestesting the blood for the presence of certain characteristics, such asthe presence or amount of one or more constituents, or to determine thelevel of one or more parameters. For many of these blood tests, only asmall sample of blood is required. After the IV catheter has beeninserted, the clinician may obtain a blood sample through a variety ofmethods. One method is to have the patient endure another needle stickeither by a needle and syringe to draw an aliquot of blood, or bypricking the patient's finger with a lancet for a few drops of blood.

Because some IV catheters of the prior art include an integrated flashchamber 26, another method is to enable access to the blood within theflash chamber 26 after the catheter 22 and needle 24 have been insertedinto the patient's vein. Usually the proximal end of the flash chamber26 is blocked by a flash plug 28. The flash plug 28 typically includes afilter material that enables air to vent from the flash chamber as theblood or fluid fills the chamber, but inhibits the blood or fluid frompassing from the flash chamber 26.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure relate to needle assemblies andmethods that include a needle guard with a flexible nose extensionhaving a fluid collection reservoir that is able to receive a smallquantity of bodily fluid from the flashback chamber of the needleassembly using integral features for controlled bodily fluid sampledistribution.

Some embodiments provide a needle assembly for sampling fluid from apatient including a needle guard, an insertion needle, and a needlehousing. The needle guard has a distal end and a proximal end. Thedistal end of the needle guard includes a nose portion and a flexiblenose extension defining a fluid collection reservoir. The proximal endof the needle guard includes a push feature. The insertion needle has asharpened distal tip, a proximal needle end and a shaft defining a lumenextending there between. The needle housing is connected to the proximalneedle end and is slideably coupled to the needle guard. The needlehousing includes a flash chamber including a wall defining a cavity. Thecavity is in fluid communication with the lumen of the insertion needleand is sealed at one end by a gas permeable flash plug. The needlehousing is moveable between an extended position in which the sharpeneddistal tip is exposed for insertion and one or more retracted positionsin which the sharpened distal tip is concealed within the needle guard.The push feature selectively engages the flash plug to divert capturedbodily fluids to the fluid collection reservoir for sampling, when theneedle housing is in one of the retracted positions.

Some embodiments can include a flexible nose extension with an externalseal through which captured bodily fluids can be expressed when theflexible nose extension is deformed. In some embodiments, a catheter hubis operably coupled to the nose portion of the needle guard in theextended position.

Some embodiments of a needle assembly include a lock mechanism thatrestricts distal movement of the needle housing after the push featureengages the flash plug and diverts captured bodily fluids to the fluidcollection reservoir. Some embodiments of a needle assembly include atwo step locking arrangement for restricting distal movement of theneedle housing that includes a first lock and a second lock. Further,the first lock can be configured to restrict distal movement of theneedle housing prior to the push feature engaging the flash plug and thesecond lock can be configured to restrict distal movement after the pushfeature has engaged the flash plug and diverted captured bodily fluidsto the fluid collection reservoir for sampling. Further, engaging thesecond lock can require a different type of user motion than required toengage the first lock.

In some embodiments, the one or more retracted positions include apartially retracted position and a fully retracted position. Further, insome embodiments, the needle housing is moveable in a proximal directionbetween: the extended position; the partially retracted position whereinthe sharpened distal tip of the insertion needle is withdrawn into theneedle guard and the push feature has not yet begun to engage the gaspermeable flash plug; and the fully retracted position in which the pushfeature has engaged the gas permeable flash plug and urged fluid fromthe flash chamber into the fluid collection reservoir of the flexiblenose extension and the needle housing is prevented from further slidingmovement. Further, the fluid collection reservoir may be deformed toopen a seal and provide trapped fluid from the flexible nose extensionfor analysis.

Some embodiments are directed to a method of sampling a bodily fluidfrom a patient with a needle assembly. The method includes providing aneedle assembly including: a needle guard including a flexible noseextension defining a fluid collection reservoir at a distal end of theneedle guard and a push feature at a proximal end of the needle guard;an insertion needle having a lumen and a sharpened distal tip; and aneedle housing operably coupled to a proximal end of the insertionneedle and slideably coupled to the needle guard, the needle housingincluding a flash chamber in fluid communication with the insertionneedle and sealed at one end by a flash plug. The method includesinserting the insertion needle to access bodily fluid that is providedthrough the lumen to the flash chamber and retracting the needle housinguntil the sharpened distal tip of the insertion needle is located withinthe needle guard. The method further includes retracting the needlehousing so that the push feature contacts the flash plug of the flashchamber and provides the bodily fluid back out the lumen into the fluidcollection reservoir of the flexible nose extension. The method alsoincludes distorting the flexible nose extension to open a seal andexpress the bodily fluid of the fluid collection reservoir in acontrolled fashion.

The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures, in which:

FIG. 1 is a perspective view depicting a peripheral intravenous catheterof the prior art in a first position.

FIG. 2 is a perspective view depicting the peripheral intravenouscatheter of the prior art of FIG. 1 in a second position.

FIG. 3 is a perspective view depicting a safety needle assembly wherethe needle is in a fully extended position, according to an embodiment.

FIG. 4 is a cross-sectional perspective view depicting a safety needleassembly where the needle is in a fully extended position, according toan embodiment.

FIG. 5 is a close up side cross sectional view depicting the nose andflexible nose extension of a safety needle assembly where the insertionneedle is retracted within the nose, according to an embodiment.

FIG. 6 is a side cross sectional view depicting a safety needle assemblywhere the needle is in a fully extended position, according to anembodiment.

FIG. 7 is a side cross sectional view depicting a safety needle assemblywhere the needle is in a partially retracted position, according to anembodiment.

FIG. 8 is a side cross sectional view depicting a safety needle assemblywhere the needle is in a fully retracted position, according to anembodiment.

FIG. 9 is a side cross sectional view depicting a safety needle assemblywhere the needle is in a fully retracted position and the fluid of thecollection reservoir is being accessed, according to an embodiment.

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedinventions to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

DETAILED DESCRIPTION

FIGS. 1 and 2 show a safety needle assembly 20 according to the priorart. Details of safety needle assembly 20 are set forth in thebackground section above. Use of a peripheral device, such as thecatheter 22 and its catheter hub 30, with the safety needle assemblies100 disclosed in FIGS. 3-9 are contemplated, although these componentsare not shown in the figures for clarity of the other features of theneedle assemblies 100 being depicted.

FIGS. 3-4 set forth a safety needle assembly 100 that includes aflexible nose extension 102 for diagnostic sample collection andsealing. Needle assembly 100 generally includes an insertion needle 104,a needle housing 106, and a needle guard 108. Insertion needle 104 has asharpened distal tip 110, a proximal end 112 and a shaft 114 defining alumen 116 extending therebetween.

Needle housing 106 is operably coupled to the proximal end 112 of theinsertion needle 104. The needle housing 106 includes a flash chamber118 comprising a wall 120 defining a cavity 122. In some embodiments,the wall 120 defining the cavity 122 can be constructed of a transparentmaterial to enable a clinician to visually see when fluid enters thecavity 122.

The cavity 122 is in fluid communication with the lumen 116 of theinsertion needle 104, according to exemplary embodiments. The distal end124 of the flash chamber 118 can include an aperture 126 that is sizedto accommodate the proximal end 112 of the insertion needle 104. Thecavity 122 can be sealed by a gas permeable flash plug 128. For example,in some embodiments, the proximal end 131 of cavity 122 can be pluggedwith a microporous flash plug 128. Flash plug 128 can be comprised of amaterial that enables air to vent from the cavity 122 as fluid fills thecavity 122, while inhibiting the fluid from passing through the flashplug 128 and out of the cavity 122. Needle housing 106 further includesa grip portion 129 located on the outside of the needle guard 108. Thegrip portion 129 enables a user to slide back the needle housing 106 inrelation to the needle guard 108 with his/her fingers.

Needle guard 108 has a distal end 130 and a proximal end 132. Distal end130 of needle guard 108 can be configured with a tapered blunt tip or“nose” 134 which further includes a flexible nose extension 102 at itstip. Passageway 127 extends through the distal end 130 of the needleguard 108, including the nose 134 through which an insertion needle 104can pass. Further, insertion needle 104 can pass through theperforations or openings present in the walls of the nose extension 102.In some versions, safety needle assembly 100 can include a catheter hubcoupling mechanism (not shown) to selectively couple a catheter hub,such as catheter hub 30, for example.

Nose extension 102 is generally a flexible elastomeric protrusion thatfeatures a central sample collection reservoir 140 defined by outerwalls 141 that include at least an outer seal 142, as shown in theexample embodiment of FIG. 5. The outer surface of nose extension 102can be various shapes, such as a cylinder or prism, for example. Thenose extension 102 facilitates continuation of a sealable passageway 127that extends from aperture 126, through which an insertion needle 104can readily pass. Insertion needle 104 spans the width of nose extension102 when the needle 104 is in the extended position. The insertionneedle 104 is fully removed from the nose extension 102 when the needle104 is in the fully retracted position, as can be seen in greater detailin the up close view of the nose 134 and flexible nose extension 102 ofFIG. 5. The contours of the outer walls 141 can form and take on variousshapes (i.e. flat, curved, round, rectangular, etc.) but can be compactenough in profile, in some embodiments, such that the nose extension 102can fit within the confines of a catheter hub mounted on the nose 134 ofthe needle assembly 100.

The sample collection reservoir 140 of the nose extension 102 can be acavity of various sizes, however, it can generally be sized toaccommodate a volume equivalent to a few drops of blood or fluid. Theouter seal 142 generally provides an annular opening in close contactwith the perimeter of insertion needle 104 when the needle is present.When the insertion needle 104 is not present, the opening is closed anda fluid-tight joinder of the elastomeric material of nose extension 102is formed. Opposite the outer seal 142 on flexible nose extension 102 isan inner aperture 144 located adjacent to the nose 134 and its centralpassageway 127. Aperture 144 generally provides a tight seal aroundinsertion needle 104, when present. However, when insertion needle 102is retracted from the aperture 144, the opening provided is generallywide enough such that it will not completely close and, accordingly,leaves the passageway 127 of nose 134 in open communication with thefluid collection reservoir 140.

Needle guard 108 can be slideably coupled to the needle housing 106. Forexample, in one embodiment, needle housing 106 can have a “C” shapedcross section conformed to fit around the outer surface of the needleguard 108 in a manner that inhibits the needle housing 106 from readilyseparating from the needle guard 108, yet enables the needle housing 106to slide along the longitudinal axis of the needle guard 108 withminimal resistance.

In some embodiments, the needle guard 108 can include structure defininga groove (not shown), and the needle housing 106 can be configured toslide along the groove, thereby inhibiting the needle housing 106 fromrotating about the longitudinal axis of the needle guard 108. In oneversion, the needle housing 106 can include a lug configured to fitwithin the groove of the needle guard 108, thereby enabling linearmovement of the needle housing 106 substantially parallel to thelongitudinal axis of the needle guard 108, but restricting rotationalmovement of the needle housing 106 relative to the needle guard 108.

Needle guard 108 can be moveable between an initial extended position(as depicted in FIGS. 3, 4, and 6), wherein the sharpened distal tip 110extends from the needle guard 108 and one or more retracted positions.The retracted positions can include a (first) partially retractedposition (as depicted in FIG. 7), wherein the sharpened distal tip 110is retracted back to the nose extension portion of the needle guard 108,and a (second) fully retracted position (as depicted in FIG. 8), whereinthe sharpened distal tip 110 is housed within the needle guard 108. Inthe initial extended position, when a catheter 22 is operably coupled tothe needle guard 108, a portion of the insertion needle 104 can extendthrough aperture 126, passageway 127, and catheter 22, such that thesharpened distal tip 110 of insertion needle 104 protrudes slightly fromthe catheter 22. In the retracted positions, the insertion needle 104 iswithdrawn from the catheter 22 and the sharpened distal tip 110 ishoused by the needle guard 108 in a manner intended to reduce oreliminate the likelihood of an inadvertent needle stick.

In some embodiments, the insertion needle 104 can be locked in positionrelative to the needle guard 108. Several different types of locks andlocking mechanisms can be used for this purpose, including single stageor multi-stage lock arrangements.

In one embodiment, the needle guard 108 defines a groove and can definea bottleneck that has a narrower width than the groove. A wedge shapedlug of the needle housing 106 can include an apex that faces thebottleneck in the first position. When the needle housing 106 is slidinto the first or second retracted position, the apex of the wedge comesinto contact with the bottleneck. As the bottleneck has a width narrowerthan that of the wedge, it will initially resist movement through thebottleneck. With sufficient force, the wedge will cause the bottleneckto temporarily deform, thereby enabling the lug to pass through thebottleneck. Thereafter, the lug will be unable to pass back through thebottleneck in the opposite direction, and the insertion needle 104 willbe locked in position relative to the needle guard 108.

Multiple locks, lock locations, or lock mechanisms may be possiblewithin the same embodiment as well. For example, this may permit lockingthe needle housing 106 in two separate locations to accommodate thedesired operation of the needle. For example, in FIG. 7, a lockmechanism 152 on needle guard 108 is shown interacting with a first locktriangle 154 that is present in the needle housing 106, to provide afirst lock 155. Further, in FIG. 8, the lock mechanism 152 on the needleguard 108 is shown interacting with a second lock triangle 156 that ispresent on the needle housing 106, to provide a second lock 157. Itshould be understood, however, that embodiments containing only a singlelock (for example, which only contain a lock 157 in the fully retractedposition) are contemplated by these figures and disclosure as well.

In FIG. 4, the proximal end 132 of the needle guard 108 includes a pushfeature 150. Push feature 150 can take on various shapes and mechanisms.In general, the push feature 150 provides a rigid or moveable structurewhich can provide a force against the flash plug 128 to control the flowof fluid in the flash chamber 118 to the collection reservoir 140. InFIG. 4, a finger-like projection extends outwardly from the wall of theneedle guard 108 before bending to a generally perpendicular orientationand extending in a generally axial direction for a short distance withinthe needle guard 108. This projection provides a rigid bar that is shownand referred to as the push feature 150. Accordingly, in thisembodiment, the rigid bar is designed so that it will contact the flashplug 128 as the insertion needle 104 is withdrawn into the needle guard108.

FIGS. 6-9 demonstrate an embodiment of the operation of the safetyneedle assembly 100, including obtaining blood or bodily fluid fordiagnostic testing. In FIG. 6, the insertion needle 104 is in the fullyextended position which provides a section of the shaft 114 beyond theneedle guard 108. This configuration is generally the initial state(i.e. “extended position”) of the safety needle assembly 100 which isused to insert a peripheral catheter or similar device (see catheter 22and catheter hub 30 in FIGS. 1 and 2, for example). Specifically, theneedle housing 106 is extended forward into its distal-most positionwith respect to the needle guard 108. The shaft 114 of the insertionneedle 104 passes from the needle housing 106, through the aperture 126,through the nose 134, through the nose extension 102, and out the distalend 130 of the needle guard 108. The outer seal 142 of the noseextension 102 is engaged around the shaft 114 of the insertion needle104 to provide a fluid-tight barrier. The cavity 122 of the flashchamber 118 is empty in this initial state and flash plug 128 is notengaged to the push feature 150 that is located near the proximal end132 of the needle guard 108.

Although not shown in FIG. 6, a catheter 22 and catheter hub 30, similarto those shown in FIGS. 1 and 2, can be mounted to the needle assembly100 in the ready position for placement, in some embodiments.Specifically, the internal passageway of the catheter hub 30 can bemounted over the insertion needle 104, nose 134, and nose extension 102.Further, the insertion needle 104 can fully extend through the catheter22 such that the sharpened distal tip 110 is exposed for patientinsertion.

Prior to patient insertion and placement of the catheter 22 from aneedle assembly 100, preparation of the biological site of the patientis generally needed. A tourniquet can be applied proximal to thebiological site and a variety of techniques can be used to dilate thepatient's vein. While wearing disposable gloves, a clinician cleansesthe biological site and a vein is retracted or anchored by placing athumb over the vein distal to the site. The needle 104 and catheter 22are introduced into the vein by inserting the bevel of the sharpeneddistal tip 110 into the vein at about a 20-30 degree angle with thebevel facing up in order to pierce one wall of the vein. If successful,blood from the vein will flow through the lumen 116 of the needle 104and into the flash chamber 118, thereby indicating that the vein hasbeen entered.

Referring to FIG. 7, a subsequent position (i.e. “first retractedposition” or “partially retracted position”) of the needle assembly 100is shown. Just prior to moving to this position, after needle insertionand flashback of fluid into the flash chamber 118, the user can performpartial withdrawal of the insertion needle 104. Namely, placement of theinsertion needle 104 is finished when the safety needle assembly 100 islowered towards the skin to decrease the entry angle, and the catheter22 is advanced slightly into the vein. The insertion needle 104 isloosened and the catheter 22 is gently advanced farther up into the veinuntil the catheter hub 30 of the catheter 22 is against the biologicalsite. The tourniquet is loosened and the insertion needle 104 iswithdrawn from the catheter 22, as the needle housing 106 is retractedfrom the extended position. The subsequent configuration is shown inFIG. 7. Specifically, a cross section of a safety needle assembly 100having a partially retracted needle 104 is shown in FIG. 7. The needlehousing 106 and the corresponding needle 104 are shown proximallyshifted within the needle guard 108 compared with FIG. 5. The distal tip110 of the needle 104 has passed through the outer seal 142 of the noseextension 102 and is shown partially extending into the collectionreservoir 140. The outer seal 142 of the nose extension 102 forms a sealat the very distal tip of the needle guard 108. In FIG. 7, the pushfeature 150 is close to initiating contact with the flash plug 128.

In some embodiments, as generally depicted in FIG. 7, a lock 155 ispresent in this position for restricting distal movement of the needlehousing 106. Specifically, the lock 155 is configured to restrict distalmovement of the needle housing prior to the push feature 150 engagingthe flash plug 128. This lock 155 may be the first lock engaged in amulti-step locking arrangement. The first lock 155 is made possiblebased on a lock mechanism 152 located on the needle guard 108 thatengages a first lock triangle 154 that is present in the needle housing106. Other types of locks or lock locations may be possible as well.Further, an initial locking configuration prior to urging fluid from theflash chamber 118, such as lock 155, is not present in variousembodiments. For example, certain embodiments may not lock the needlehousing 106 until the needle 104 is fully retracted.

Upon further needle retraction, when the push feature 150 contacts theflash plug 128, the safety needle assembly 100 forces the fluid from theflash chamber 118, through the insertion needle 104 and into the samplecollection reservoir 140. Specifically, as the insertion needle 104 iswithdrawn into the needle guard 108, the rigid push feature 150 engagesthe proximal portion of the porous barrier comprising the flash plug 128in the flash chamber 118. As this engagement and the needle retractionmovement occurs, the flash plug 128 (i.e. porous barrier) is forced intothe flash chamber 118 by the rigid push feature 150. The flash plug 128acts like a plunger to force the fluid sample into the collectionreservoir 140. Because the needle assembly 100 can be designed with apush feature 150 sized for a desired fluid volume displacement from theflash chamber 118, the amount of fluid provided to the sample collectionreservoir 140 can accordingly be well-controlled and suitable amounts offluid made available via the reservoir 140 for sampling.

Referring to FIG. 8, the safety needle assembly 100 is shown where thecollection reservoir has been filled and the insertion needle 104 hasmoved proximally to a fully retracted position (i.e. “second retractedposition” or “fully retracted position”). In this position, theinsertion needle 104 can be safely locked within needle guard 108 asshown. Specifically, within the needle guard 108, the sharpened distaltip 110 of the insertion needle 104 is fully contained within the nose134. Further, the needle housing 106 has been moved to the proximalportion of needle guard 108 and the push feature 150 is shown in contactwith the flash plug 128 such that flash plug 128 has been urgedpartially into the cavity 122 of flash chamber 118. This urging hascaused plunging of fluid down the insertion needle 104 from the flashchamber 118 into the fluid collection reservoir 140.

In terms of locking arrangements, the lock mechanism 152 on the needleguard 108 is shown interacting with a second lock triangle 156 that ispresent on the needle housing 106, to provide a second lock 157. Itshould be understood, however, that embodiments containing only a singlelock (i.e. only containing a lock 157 in the fully retracted position)are contemplated by these figures and disclosure as well. In general,second lock 157 restricts distal movement of the needle housing 106after the push feature 150 engages the flash plug 128 and divertscaptured bodily fluids to the fluid collection reservoir 140 forsampling.

Accordingly, a two step locking arrangement is made possible forrestricting distal movement of the needle housing 106 that includes afirst lock 155 and a second lock 157. Needle retraction, accordingly,can be split into a two step process so that a user can either elect tomerely safely retract the insertion needle 104 or to retract theinsertion needle 104 and additionally fill the collection reservoir 140of the nose extension 102 for diagnostic sampling as well. This splitprocess enables a user input on whether a diagnostics fluid sample isdesired. The first step retracts the insertion needle 104 in a normalfashion without filling the reservoir with fluid. For users who do notwish to sample the fluid of the flash chamber 118, this is the finalstep. For users who wish to sample the fluid, a second action will becompleted to further advance the insertion needle 104 to a point wherethe push feature 150 contacts and moves the flash plug 128.

In some embodiments, engaging the second lock 157 will be deigned torequire a different type of user motion than required to engage thefirst lock 155. For example in addition to a linear proximal movement toengage a first lock 155, a rotation or similar movement could engage thesecond lock 157. This type arrangement could help avoid unintentionalpreliminary locking of the needle assembly 100. In certain embodiments,needle retraction will be designed to include filling of a collectionreservoir 140 of the nose extension 102 by default and merely rely on asecond lock 157 without the inclusion of a first lock 155. In suchembodiments, retraction of the needle housing 106 will automaticallyprovide fluid in the collection reservoir 140 that is available fordistribution and sampling.

As shown in FIG. 9, the safety needle assembly 100 provides easysampling of fluid from a filled collection reservoir 140 inside noseextension 102 to a test strip 160. Specifically, the fluid insidecollection reservoir 140 can be accessed by pressing the flexible tip ofthe nose extension 102 inward from the side, for example. This sidepressure opens the distal tip outer seal 142 and allows access to thefluid sample, such as by controlled expression of drops of blood orfluid. Some embodiments, the nose extension 102 can be pressed against asampling strip 160 or other sampling item's surface to distort a wall141 of the nose extension 102 to open the distal tip outer seal 142.Accordingly, one or more drops of blood or fluid can be deposited in ahighly controlled manner. For example, embodiments may utilize fluidsampling strips 160, such as a blood glucose monitoring test strip orother similar test strip, device or mechanism. Permitting access tofluids in this way enables a high level of control and accuracy to fluidsampling.

In general, a needle assembly 100 can therefore be used, in operation,to sample a bodily fluid from a patient In one operation, a needleassembly 100 is provided that includes: a needle guard 108 including aflexible nose extension 102 defining a fluid collection reservoir 140 ata distal end 130 of the needle guard 108 and a push feature 150 at aproximal end 132 of the needle guard 108; an insertion needle 104 havinga lumen 116 and a sharpened distal tip 110; and a needle housing 106operably coupled to a proximal end 112 of the insertion needle 104 andslideably coupled to the needle guard 108 where the needle housing 106includes a flash chamber 118 in fluid communication with the insertionneedle 104 and is sealed at one end by a flash plug 128.

Next, in this operation, the insertion needle 104 is inserted in thepatient to access bodily fluid that is provided through the lumen 116 tothe flash chamber 118 and retracting the needle housing 106 until thesharpened distal tip 110 of the insertion needle 104 is located withinthe needle guard 108. Additionally, the needle housing 106 is retractedso that the push feature 150 contacts the flash plug 128 of the flashchamber 118 and provides the bodily fluid back out the lumen 116 intothe fluid collection reservoir 140 of the flexible nose extension 102.Next, the flexible nose extension 102 is distorted to open a seal 142and express the bodily fluid of the fluid collection reservoir 140 in acontrolled fashion.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed inventions. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

What is claimed is:
 1. A needle assembly for sampling fluid from apatient, comprising: a needle guard having a distal end and a proximalend, the distal end of the needle guard including a nose portion and aflexible nose extension that defines a deformable fluid collectionreservoir including an outer seal, the proximal end of the needle guardincluding a push feature; an insertion needle having a sharpened distaltip, a proximal needle end and a shaft defining a lumen extendingtherebetween; and a needle housing operably coupled to the proximalneedle end and slideably coupled to the needle guard, the needle housingincluding a flash chamber comprising a wall defining a cavity, thecavity in fluid communication with the lumen of the insertion needle andsealed at one end by a gas permeable flash plug; wherein the needlehousing is moveable between an extended position in which the sharpeneddistal tip is exposed for insertion and one or more retracted positionsin which the sharpened distal tip is concealed within the needle guard;wherein the push feature is selectively engagable with the flash plug tourge captured bodily fluids from the flash chamber into the fluidcollection reservoir, when the needle housing is in one of the one ormore retracted positions; and wherein the bodily fluid in the fluidcollection reservoir is accessible by applying an external pressure tothe flexible nose extension, so as to deform the fluid collectionreservoir and open the outer seal for expression of at least a portionof the bodily fluid therein.
 2. The needle assembly of claim 1, furthercomprising: a lock mechanism that is configured to restrict distalmovement of the needle housing after the push feature engages the flashplug and urge captured bodily fluids to the fluid collection reservoir.3. The needle assembly of claim 1, further comprising a two step lockingarrangement for restricting distal movement of the needle housing thatincludes a first lock and a second lock.
 4. The needle assembly of claim3, wherein the first lock is configured to restrict distal movement ofthe needle housing relative to the needle guard prior to the pushfeature engaging the flash plug and wherein the second lock isconfigured to restrict distal movement of the needle housing relative tothe needle guard after the push feature has engaged the flash plug anddiverted captured bodily fluids to the fluid collection reservoir forsampling.
 5. The needle assembly of claim 4, wherein the first lock isconfigured to be engaged with a first type of user motion; and thesecond lock is configured to be engaged with a second type of usermotion.
 6. The needle assembly of claim 1, wherein the one or moreretracted positions include a partially retracted position and a fullyretracted position.
 7. The needle assembly of claim 6, wherein theneedle housing is moveable in a proximal direction between: the extendedposition; the partially retracted position wherein the sharpened distaltip of the insertion needle is withdrawn into the needle guard and thepush feature has not yet begun to engage the flash plug; and the fullyretracted position in which the push feature has engaged the flash plugand urged fluid from the flash chamber into the fluid collectionreservoir of the flexible nose extension and the needle housing isprevented from further sliding movement.
 8. The needle assembly of claim1, wherein a catheter hub is operably coupled to the nose portion of theneedle guard in the extended position.